VISP (Toole) trial

VISP (Toole) study, 2004	TRC8857
	download pdf: high dose - folic acid, vit B12 and vit B6 \| plasma homocysteine lowering intervention for cardiovascular prevention

Treatments

Studied treatment	high-dose of folic acid, pyridoxine (vitamin B6), and cobalamin (vitamin B12) 25 mg of pyridoxine, 0.4 mg of cobalamin, and 2.5 mg of folic acid
Control treatment	low-dose of folic acid, pyridoxine (vitamin B6), and cobalamin (vitamin B12) 200 ìg of pyridoxine, 6 ìg of cobalamin, and 20 ìg of folic acid

Patients

adults with nondisabling cerebral infarction

Inclusion criteria

Nondisabling ischemic stroke(Modified Rankin Stroke Scale <=3), onset <=120 days before; focal neurological deficit of likely atherothrombotic origin, classified as ischemic stroke by questionnaire/algorithm or confirmed as new cerebral infarction, consistent with symptoms by cranial computed tomography or brain magnetic resonance imaging; total homocysteine level >=25th percentile for North American stroke population; age >=35 years

Baseline characteristics

Age (yr)	66 y
Male sex	63%
BMI	28.1
diabetes (%)	29%

Method and design

Randomized effectives	1827 / 1853 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	2 y
Lost to follow-up	0.84% (31/)
Number of centre	56
Geographic area	United States, Canada, Scotland
Hypothesis	Superiority
Primary endpoint	Recurrent cerebral infarction

Results

Endpoints and data reported in the trial's publication(s)

Endpoint	Events (%)		Relative Risk	95% CI
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI
Any Ischemic stroke	152 / 1827 (8,3%)	148 / 1853 (8,0%)	1,04	[0,84;1,29]
Fatal or disabling Ischemic stroke	21 / 1827 (1,1%)	18 / 1853 (1,0%)	1,18	[0,63;2,21]
Any CHD	114 / 1827 (6,2%)	123 / 1853 (6,6%)	0,94	[0,73;1,20]
MI or fatal CHD	72 / 1827 (3,9%)	81 / 1853 (4,4%)	0,90	[0,66;1,23]
Any Ischemic stroke or CHD	249 / 1827 (13,6%)	257 / 1853 (13,9%)	0,98	[0,84;1,16]
Fatal or disabling stroke or MI or fatal CHD	89 / 1827 (4,9%)	98 / 1853 (5,3%)	0,92	[0,70;1,22]
Death	99 / 1827 (5,4%)	117 / 1853 (6,3%)	0,86	[0,66;1,11]
Ischemic stroke, CHD, death	303 / 1827 (16,6%)	316 / 1853 (17,1%)	0,97	[0,84;1,12]
Fatal or disabling stroke, MI, death	156 / 1827 (8,5%)	170 / 1853 (9,2%)	0,93	[0,76;1,15]

Endpoints used by the meta-analysis and data retained for this trial

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

All cause death

99 / 1827
117 / 1853
0,86 [0,66;1,11]

stroke (fatal and non fatal)

152 / 1827
148 / 1853
1,04 [0,84;1,29]

Non fatal MI

72 / 1827
81 / 1853
0,90 [0,66;1,23]

cardiovascular events

303 / 1827
316 / 1853
0,97 [0,84;1,12] 0 2 1.0

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial	Ref
All cause death	99 / 1827 (5,4%)	117 / 1853 (6,3%)	0,86	[0,66;1,11]	Death	0
Non fatal MI	72 / 1827 (3,9%)	81 / 1853 (4,4%)	0,90	[0,66;1,23]	MI or fatal CHD	0
cardiovascular events	303 / 1827 (16,6%)	316 / 1853 (17,1%)	0,97	[0,84;1,12]	Ischemic stroke, CHD, death	0
stroke (fatal and non fatal)	152 / 1827 (8,3%)	148 / 1853 (8,0%)	1,04	[0,84;1,29]	Any Ischemic stroke	0
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 0:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction (for a follow-up of 2 y)
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
All cause death	5,42%	6,31%	-0,90%
Non fatal MI	3,94%	4,37%	-0,43%
cardiovascular events	16,58%	17,05%	-0,47%
stroke (fatal and non fatal)	8,32%	7,99%	0,33%

Meta-analysis of all similar trials:

plasma homocysteine lowering intervention in cardiovascular prevention for all type of patients

prevention in post stroke for patients with prior stroke or TIA

Reference(s)

TrialResults-center ID	TRC8857
Trials register #	NA